SBIR-STTR Award

Empirical proposes to further develop and clinically validate a complete solution for a rugged, multi-parameter, vital signs monitor. The device, CareTaker, fits inside the palm like a small hockey puck and attaches to a small finger cuff. Once calibrated with a conventional sphygmomanometer, CareTaker will continuously monitor beat by beat blood pressure, heart rate, respiration rate, and hemorrhaging for 100 hours on a battery charge. Two temperature sensors and a provision for an oximeter will be added to the hardware. The software will be embedded into a new processor within the device. Communicating with CareTaker is via Bluetooth to PDAs, PCs, or smart phones. Charts representing trends in physiological parameters may be uploaded. Notes may be added to the virtual chart that will follow the patient to hospitals and home. An LCD is available for radio free use. One proposed clinical investigation will use CareTaker on patients in a MICU who have an arterial catheter. This will verify the ability of CareTaker to accurately track changing blood pressure. Another clinical investigation will use blood donors who effectively hemorrhage a pint of blood. This will verify that CareTaker can effectively monitor bleeding, whether internal, external, or under a bandage.

Keywords:
Vital Signs Monitor, Hemorrhagic Shock Monitor, Hemorrhage, Blood Pressure, Heart Rate, Respiriation Rate,Multi-Parameter, Portable

CareTaker is a small, battery powered, light, inexpensive, portable physiological monitor that records central blood pressure, beat by beat. It is comfortable, fits in the palm of the hand, may be worn continuously for days, remembers extracted parameters, has Bluetooth capability and interfaces with other Bluetooth devices including oximeters. Heart rate is recorded nearly as accurately as ECG allowing for computation of HRV. Most importantly, CareTaker has a shown great sensitivity in lower body negative pressure chamber; its T13 parameter is equivalent to blood volume. This proposal will verify long term accuracy using arterial catheters, show through blood donations that small amounts of hemorrhaging can be detected, and verify that its technology can detect dehydration and perhaps hypoxia. CareTaker is ideally suited for replacement of arterial catheters and has many applications in clinics and in the home. It is a new device based on the theory of reflections in the arterial tree and is leading to new insights and uses in medicine.

Keywords:
Continuous Blood Pressure, Hypovolemia, Heart Rate Variability,Patient Monitoring, Combat Casualty Care, Miniature, Portable, Medical